Position Overview
Our client is a clinical-stage biopharmaceutical company focused on building the future of oncological therapy to improve patient outcomes.
The Head of Drug Safety and Pharmacovigilance (PV), is responsible for the leadership and oversight of Pharmacovigilance and Safety for our client. The Head of Safety must possess a strong knowledge of US and global pharmacovigilance regulations, operational efficiencies, information systems, and best industry practices to effectively solve PV challenges and facilitate PV Compliance. This role sits on the CMO leadership team and reports into the Chief Medical Officer.
Key Responsibilities
- Provide medical oversight of the PV function including medical review of all cases inclusive of case narratives and causality assessments of AE/SAE reports.
- Create and maintain a signal detection process (including regular and ad hoc reviews of aggregate safety data) for our client
- Coordinate safety governance within the company and ensure cross-functional involvement in the evaluation of potential emerging safety issues and any associated risk mitigation and management measures that are proposed.
- Participate as a key stakeholder in safety analyses and ensure proactive and timely benefit-risk assessments of safety data.
- Represent PV in communication with health and regulatory authorities including management of the DSUR process and being signatory for DSUR, PAER and other safety reports to FDA and other health authorities
- Represent our client at independent Data Safety Monitoring Committee meetings.
- Design and implementation of Risk Management plans
- Compile analysis of adverse events of special interest (AESI), individual case comments, risk management plan implementation, and ad hoc safety analysis as required by health authorities or corporate policy.
- Serve as SME author, reviewer, and approver for drug-safety related regulatory reports and clinical study documents (including Clinical Study Protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), product package labeling, Company Core Safety Information, etc).
- Effective interpersonal, communication and influencing skills, including excellent writing skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems.
- Strong learning orientation, curiosity, and commitment to science and patients.
- Lead and supervise a high performing PV function
- Develop operating plans and budgets and allocate resources to ensure budgets, schedules, and performance requirements are met.
- Work cross functionally aligning the company priorities with cross-functional partners
- Perform all duties in keeping with our client’s core values, policies and all applicable regulations.
Key Requirements
- Clinical Degree (RN, PharmD, MD/DO) with 15+ years of industry experience is required.
- 15 or more years of experience in the biotechnology or pharmaceutical industry with knowledge of GCP, clinical trial conduct, data interpretation, and safety in clinical development. A mix of large and small company experience highly preferred.
- Extensive experience interfacing with US Health Authorities in Safety/Pharmacovigilance areas required.
- Experience with NDA/sNDA submissions
- PV experience for products in clinical development and for post marketed products is a must
- Excellent scientific, clinical and analytical knowledge base, with ability to assess data and understand the safety and medical implications.
- In-depth understanding and experience with causality assessment science for adverse events
- Expert knowledge of the regulations governing pharmacovigilance.
- In-depth knowledge of Safety Science and Safety Operations disciplines, with a working knowledge of internally and externally managed safety systems and databases.
- Direct management experience with proven ability to effectively lead, coach, mentor, and manage others.
- Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment
Location(s)
Boston, MA
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